Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
1 other identifier
observational
20
1 country
1
Brief Summary
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 10, 2018
April 1, 2018
3.2 years
June 3, 2014
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in frailty following left ventricular assist device implantation
Frailty will be assess based on the domains initially described by Fried and colleagues: weakness, low physical activity, unintentional weight loss, slowness and exhaustion. Additional frailty measures include the Short Physical Performance Battery (SPPB), as well as gait speed and hand grip strength as single item measures.
Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively
Secondary Outcomes (1)
Skeletal muscle size as measured by ultrasonography
Baseline (prior to surgery); 10 days and 3 months postoperatively
Other Outcomes (1)
Cognitive function measured by the Montreal Cognitive Assessment
Baseline; 3 and 6 months post-operatively
Study Arms (1)
Older, left ventricular assist device
Older heart failure patients undergoing left ventricular assist device implantation
Eligibility Criteria
Consecutive heart failure patients 60 years old or older undergoing left ventricular assist device implantation.
You may qualify if:
- years old or older
- Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University
You may not qualify if:
- Unable or unwilling to provide informed consent
- Unable to complete baseline frailty assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Jefferson Universitylead
- Thoratec Corporationcollaborator
- National Skeletal Muscle Research Centercollaborator
- Greater New York Geriatric Cardiology Consortiumcollaborator
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Maurer MS, Horn E, Reyentovich A, Dickson VV, Pinney S, Goldwater D, Goldstein NE, Jimenez O, Teruya S, Goldsmith J, Helmke S, Yuzefpolskaya M, Reeves GR. Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or Reverse Frailty? J Am Geriatr Soc. 2017 Nov;65(11):2383-2390. doi: 10.1111/jgs.15124. Epub 2017 Sep 21.
PMID: 28940248RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon R Reeves, MD, MPT
Thomas Jefferson University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 5, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 10, 2018
Record last verified: 2018-04